The present invention relates to a novel breast localization needle which may be readily inserted and anchored within the body tissue to identify to the surgeon the location of nonpalpable lesions.
During the past thirty years, there has not been a substantial increase in the rate of survival in the treatment of breast cancer using a surgical radiation therapy or chemotherapeutic treatment of the breast lesions, with the five year survival rate still being approximately 50%. However, if very small lesions, less than one centimeter in size, are detected early and appropriately surgically removed, the rate of survival is between 92 to 97%. The use of mammography, or X-ray examination, of the breast has been able to detect small lesions or tumors in asymptomatic females. Although, these lesions can be identified by X-ray examination, their surgical removal is often times difficult because they are small in size and they are difficult to precisely locate, especially in large breasts, and in the case where the lesions are located deep within the tissue mass.
To aid the surgeon in locating the nonpalpable lesions within the breast, Kopans has suggested and disclosed a technique (Radiology, March, 1980, Vol 128, p. 781) wherein a hypodermic needle is initially placed into the breast to locate the breast lesion. After the needle is positioned in the breast, the location is optimally confirmed by using two mammographic or X-ray positions. During these mammographic filmings the breast is compressed to confirm the positioning of the needle at or adjacent to the breast lesion. When the needle is properly placed, a stainless steel wire having a hairpin hooked-end portion is slid through the needle wherein the hooked hairpin-end portion exits from the needle to engage the body tissue to retain the needle adjacent to or at the breast lesion. Upon the exit of the hooked portion to engage the breast tissue, an additional set of mammograms is taken to verify the position of the hook, wire and needle with respect to the breast lesion. If the position is correct, the introducing needle is withdrawn over the wire and the wire is anchored to the tissue and the patient is taken to surgery. The wire permits the surgeon to know where the lesion lies within the breast tissue.
However, the Kopans' needle and wire-hook arrangement possesses several disadvantages because during mammographic filming of the breast lesion and location of the needle within the breast, the breast is compressed which can cause the needle to move or be displaced with respect to the breast lesion. Additionally, after the hairpin hook wire has been inserted through the needle and expanded to anchor the Kopan's needle/hook-wire apparatus in place, a second set of mammograms is required to verify the positioning of the needle within the breast tissue. If the position is incorrect, the hooked wire cannot be easily removed and forceful removal results in considerable damage to the tissue as well as the fact that the ultimate removal of the hook-wire from the breast causes undesirable tearing and damage to the breast tissue.
More recently, Homer has disclosed a needle/wire device and technique (Radiology, October, 1985, Vol. 157, pp. 259-260) which includes a curved-end wire which is made of tough pseudo-elastic alloy which possesses a memory. A needle containing a wire having a J-shaped hook on the end is inserted into the breast and advanced to identify the location of the breast lesion. The wire is then advanced inwardly such that the curved hooked end engages the body tissue to immobilize the needle during mammography imaging to insure that the needle is correctly positioned at or adjacent the breast lesion. Although such a curved J-shaped retractable wire within a stylus eliminates the need for multiple X-rays, the needle and hook device can be relatively easily displaced if traction or pressure is applied to the breast during transport of the patient or during surgery. Thus, actual migration of the hook-wire device in the breast tissue occurs during surgery and movement of the patient to surgery.